Drug product
traMADol HCl Tablet, 25 mg (1/2 of 50 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57664037708
D-626-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-626-2014
Official wording
Reason: Labeling:Label Mixup; traMADol HCl Tablet, 25 mg (1/2 of 50 mg) may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 137 mcg, NDC 00527163801, Pedigree: AD60272_76, EXP: 5/22/2014.
Code information: traMADol HCl, Tablet, 25 mg (1/2 of 50 mg) has the following code Pedigree: AD60272_92, EXP: 5/22/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled